HHS to Repeal SUNSET Rule Tuesday, April 27, 2021
By way of background, on January 19, 2021, the Department of Health and Human Services (HHS) issued the final “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET) rule which would have amended nearly all of the approximately 18,000 HHS regulations to add self-executing expiration dates.
Specifically, the final rule stated that “subject to certain [undefined] exceptions,” all regulations in Titles 21, 42, and 45 of the CFR would expire on the later of the following dates: (1) five years after the effective date of the rule [originally March 22, 2021 and later delayed to March 22, 2022], (2) ten years after the regulation’s promulgation, or (3) ten years after HHS assessed and (if required) reviewed the regulation to determine if the regulation should be rescinded or modified to minimize its impacts on small entities. And, because over 17,000 of HHS’s rules are more than five years old, to av
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The Big Picture
On January 8, the U.S. Department of Health & Human Services (HHS) released a final rule that imposes a ten-year sunset date on most regulations that have ever been, or will ever be, issued by HHS and its component agencies, including the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA).
1 To preserve a rule past this automatic expiration date, HHS must assess whether the rule significantly affects “small entities”; if so, HHS must publish an analysis of whether the rule ought to be preserved, amended or rescinded, as described below.
The so-called SUNSET rule which stands for “Securing Updated and Necessary Statutory Evaluations Timely” was finalized largely as proposed in November. The most significant difference pertains to the timeline for reviewing the backlog of rules that are already more than ten years old: HHS now has five years to complete these assessments, up from two years in the proposed rule. Other not